US Specs

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PURCHASE SPECIFICATIONS FOR
NUAIRE PHARMAGARD™ NU-PR797
POSITIVE PRESSURE RECIRCULATING STERILE ISOLATOR
The intent herein is to provide a concise statement of requirements for a quality Sterile Products
Compounding Isolator, which may be used to augment your purchase request/order.
The NU-PR797 meets the barrier isolator requirements of the USP 797, Pharmaceutical Compounding
Sterile Preparations.
NuAire sales representatives will be pleased to explain the importance of the performance and control
affected by each of the following requirements. The NuAire NU-PR797 meets all of the requirements in the
following SPECIFICATION.
1.
Dimensions Inches (mm)
Overall Dimensions
Width (W)
Depth (D)
Height (H)
(minimum w/optional adjustable basestand)
*2.
NU-PR797-400
50 (1270)
32-1/2 (826)
51-1/2 (1308)
78 (1981)
NU-PR797-600
74 (1880)
32-1/2 (826)
51-1/2 (1308)
78 (1981)
Workzone
Interior Dimensions
Width (W)
Depth (D) (center of gloveport)
Height (H)
35-1/4 (895)
23-1/4 (591)
27-3/8 (695)
59-1/4 (1505)
23-1/4 (591)
27-3/8 (695)
Interchange
Interior Dimensions
Width (W)
Depth (D) (at worksurface)
Height (H)
14-1/8 (359)
24 (610)
27-3/8 (695)
14-1/8 (359
24 (610)
27-3/8 (695)
Cabinet shall provide performance as specified.
a.
Cabinet shall maintain a positive pressure with in workzone and slightly less positive
pressure in the interchange to assure preparation and transfer sterility.
b.
Cabinet shall provide better than ISO Class 5 (Federal Standard 209E Class 100) within
workzone and interchange.
c.
Supply HEPA filter shall be the full length of the cabinet workzone providing better than ISO
Class 5 Laminar Downflow designed to eliminate cross contamination on the worksurface.
d.
Supply HEPA filter shall be protected by perforated metal diffusers covering the entire top of
both workzone and interchange.
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*3.
The cabinet shall be ergonomically designed for maximum user comfort and process efficiency.
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*4.
Cabinet shall have a centrally located instrument panel within the control center that is easily
serviced with quick disconnects.
Cabinet shall have the capability of incorporating a user adjustable base stand as an option.
Cabinet shall have a hinged window slanted 10° from vertical for optimal work with glove ports.
The hinged window shall allow full access to entire workzone and interchange.
Cabinet shall have (2) independent worktrays for workzone and interchange being removable
with coved corners for easy cleaning.
Cabinet shall have large exterior hinged transfer door 9-1/4” x 18” (235 x 457mm) minimum for
efficient product movement in and out of the transfer chamber.
Cabinet shall have large interior sliding door 8-1/2” x 18-1/2” (216 x 470mm) minimum for
efficient product movement in and out of the workzone.
The cabinet shall have all filter positive pressure plenums surrounded by a vacuum relative to the
room.
5.
Electrical power shall be supplied with a 12-foot (2.5m), 3-wire cord with hospital grade plug.
Electrical supply should be 115VAC, 60Hz protected with thermal circuit breaker from distribution
panel.
*6.
The cabinet shall have two internal electrical circuits; one for blower/lights and one for the hospital
grade duplex outlet. Each circuit shall be protected with a fuse located in the Control Center.
7.
The cabinet shall be listed by Underwriters Laboratories to meet the requirements of both the U.S.
and Canada for electrical/mechanical integrity.
8.
Total cabinet airflow shall be controlled via a solid-state motor voltage regulator with adjustment
available on the Control Center.
*9.
Balancing of cabinet positive pressure shall be accomplished with integrated prefilter/HEPA filter
assembly.
10.
The cabinet shall be easily transportable through a standard 36 inch (914mm) wide door without
disassembly.
11.
Fluorescent lighting shall be externally mounted and provide 40 (430) to 80 (860) foot-candles
(LUX) on work surface. The ballast is to be electronic containing thermal protection with automatic
reset.
12.
Cabinet shall have two minihelic gauges to display positive pressure of workzone and interchange
area.
13.
Cabinet shall come standard with one hospital grade duplex with drip proof cover on back wall.
*14.
Cabinet shall be easily bench mounted or freestanding console model with the addition of the
optional bench mount support or various basestand options.
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15.
Cabinet workzone shall be all 16 GA. stainless steel and reinforced with stainless steel “U” channels
to minimize vibration.
16.
Cabinet shall have a large removable workzone worktray with integral hinged support rods to be
raised and held up for cleaning.
*17.
Cabinet shall have a permanent positive pressure plenum with quick release supply filter removal.
*18.
Cabinet shall be capable of front/top filter removal without disassembly of the control panel and
hinged window hardware.
19.
Cabinet shall have a three-position IV bar with 6 hooks.
20.
The following optional equipment shall be available to support installation and user requirements:
Hospital Grade Ground Fault Interrupter for Electrical System
Additional Service Valves for Gas, Air, Vacuum
Additional Hospital Grade Duplex
Bench Mount Support
Telescoping Support Stand
Storage Pullout Trays
Pull Out Shelf
Cord Pass-Through
Adjustable Automatic Base Support Stand with Castors
Adjustable Automatic Base Support Stand with Leg Levelers
Waste/Sharps (Sm) Disposable System for Non-Hazardous Drugs
Sharps/Sharps (Lg) Disposable System for Non-Hazardous Drugs
Pharmagard™ Digital Monitor
Custom Options Available
*Having all of these features is unique ONLY to NuAire cabinets.
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Pharmagard™ Positive Pressure
Recirculating Sterile Isolator
Models NU-PR797-400/600
Catalog Number
NU-PR797-400
NU-PR797-600
Nominal 4 foot (1.2m)
Nominal 6 foot (1.8m)
Catalog Number
Performance Specifications
1. Product Protection
Style of Isolator
Isolator Construction
Interchange Chamber
Diffuser for Air Supply (Metal)
HEPA Filter Seal Type:
Supply Filter-99.99% Eff. on 0.3 microns
Intake Filter-99.99% Eff. on 0.3 microns
Standard Services:
Hospital Grade Duplex Outlet
Optional Services:
Service Valves 3/8" NPT
Isolator Size Inches (mm):
Height
Height (Minimum w/opt. Adjustable Base Stand)
Width
Depth (with Control Center)
Work Zone Inches (mm):
Width
Height
Depth (Center of Glove Port)
Interchange Inches (mm)
Width
Depth (at Work Surface)
Height
Hinged Viewing Window (Polycarbonate)
Heat Rejected, BTU, Per Hour
Electrical:
Volts, AC 60 Hz
Amps: Blower/Lights
Amps: Hospital Grade Duplex
Amps: Total
12 ft. Hospital Grade Power Cord (one)
*Crated Shipping Weight:
*Net Weight:
Net Optional Adjustable Automatic Base Stand Wt:
Net Optional Telescoping Base Stand Wt:
Net Optional Bench Mount Wt:
ISO Class 5 (Laminar Flow)
Bench top/console Isolator
Welded stainless steel 16GA, Type
304 pressure tight design
ISO Class 5 With Internal/External
Sealed Doors
Non-flammable
ISO Class 5 (Laminar Flow)
Bench top/console Isolator
Welded stainless steel 16GA,
Type 304 pressure tight design
ISO Class 5 With
Internal/External Sealed Doors
Non-flammable
Neoprene, Springloaded
Under Negative Pressure
Neoprene, Springloaded
Under Negative Pressure
One, Backwall
One, Backwall
Up to 3
Up to 3
51 1/2 (1308)
78 (1981)
50 (1270)
32 1/2 (826)
51 1/2 (1308)
78 (1981)
74 (1880)
32 1/2 (826)
35 1/4 (895)
27 3/8 (695)
23 1/4 (591)
59 1/4 (1505)
27 3/8 (695)
23 1/4 (591)
14 1/8 (359)
24 (610)
27 3/8 (695)
Fully closed to fully open
539
UL/UL-C Listed
115
3
3
6
14 GA - 3 Wire, 15A
475 lbs./220 kg.
425 lbs./193 kg.
150 lbs./68 kg.
60 lbs./27 kg.
20 lbs./19 kg.
14 1/8 (359)
24 (610)
27 3/8 (695)
Fully closed to fully open
880
UL/UL-C Listed
115
5
3
8
14 GA - 3 Wire, 15A
625 lbs./284 kg.
575 lbs./261 kg.
160 lbs./73 kg.
70 lbs./32 kg.
20 lbs./19 kg.
* For total weight, must select and add (1) of (3) base options.
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